KCT0003761招募中未知
A 12 week, multi-center, double-blind, randomized, placebo-controlled clinical trial for the evaluation of the efficacy and safety of WSY-S on treatment of stomach health
Kyung Hee University Hosipital at Gangdong0 个研究点目标入组 80 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 20(Year) 至 70(Year)（—）
- 性别
- All
入选标准
- •1) Men and women over 20 years old and under 70 years old
- •2) Those diagnosed with functional dyspepsia (Rome IV *)
排除标准
- •1) Patients with a history of severe malignancy, cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina, myocardial infarction, heart failure, arrhythmia requiring treatment) within the past 6 months. (In the case of a stable subject, the examiner can include those subjects by judgment.)
- •2) Those with a history of peptic ulcer and reflux esophagitis within 6 months
- •3) Patients who had previous gastric acid suppression surgery or gastroesophageal surgery
- •4) Patients with a history of gastrointestinal malignancies
- •5) Within 2 weeks of the start of the study, a combination of an H2 receptor blocker, an anticholinergic agent (muscarinic receptor antagonist), a gastrin receptor antagonist, a prostaglandin agent, a proton pump inhibitor, a gastric mucosal protective agent
- •6) Persons who are to continue taking medications that may cause gastritis, such as corticosteroids, non-steroidal anti-inflammatory drugs, and aspirin
- •7) Drinker: for men who consumed more than 14 units of alcohol per week and for women who consumed more than 7 units of alcohol per week during the past month
- •8) Patients with uncontrolled hypertension (over 160 / 100mmHg, measured after 10 minutes of test subjects)
- •9) Unregulated diabetic patients (fasting blood sugar 180 mg/dl or more)
- •10) Creatinine is at least twice the normal upper normal limit
- •11) AST/ALT is at least three times the normal upper limit of the test laboratory.
- •12) Patients with uncontrolled thyroid disease
- •13) Those planning to become pregnant within 3 months, during pregnancy or lactation
- •14) Those who have participated in another human application test within one month, or are planning to participate in another human application test during this human application period
- •15) Any person deemed inappropriate for this study
研究者
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